Pfizer Inc.'s IBRANCE (palbociclib) supplemental New Drug Application was accepted by the U.S. Food and Drug Administration last week.
The application includes information from the Phase III PALOMA-2 trial, which evaluated IBRANCE combined with letrozole on 666 women. The participants were postmenopausal with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer.
“Since its introduction in 2015, more than 45,000 patients have been prescribed IBRANCE by more than 9,000 providers in the U.S.,” Liz Barrett, Pfizer Oncology's global president and general manager, said. “We are pleased that the PALOMA-2 trial has further demonstrated the significant clinical benefit of IBRANCE in the first-line setting, providing additional evidence for its continued use as a standard of care medicine.”
IBRANCE is an oral inhibitor of cyclin-dependent kinases 4 and 6. CDKs regulate cell cycle progression and cell division. The PALOMA-1 study in 2014 showed that the progression free survival doubled when palbociclib was added to letrozole, from approximately 10 to more than 20 months.
The PALOMA-2 clinical trial compared IBRANCE plus letrozole versus letrozole plus placebo. The combination of IBRANCE and letrozole as a first-line treatment also improved the participants' progression-free survival rate.
